Research Involving Human Subjects

Introduction

The purpose of this Policy and Procedure is to assist investigators planning to conduct research involving human subjects in designing their research and submitting it for approval.

Human subjects research must be reviewed if conducted by any faculty, staff, students, or any other person under the auspices of the College.

Statement of Policy

In accordance with state and federal regulations and professional standards of ethical conduct, it is the responsibility of the College to reasonably ensure that, in research conducted under its auspices, the rights and welfare of human subjects are adequately protected. The primary responsibility for protecting human subjects, however, rests with each individual who initiates, directs, or engages in research.

In order for the College to fulfill its responsibility, the College has established an Institutional Review Board (IRB). The IRB is authorized to review and approve all research involving human subjects conducted under the auspices of the College, regardless of the source of funding. a. "Human Subjects Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. It does not include research using published or publicly available documents or research on elected or appointed public officials or candidates for public office. b. The members of the IRB are appointed to a three-year term by the provost and chief academic officer. In addition to other requirements of state and federal regulations, the membership of the IRB shall be composed of individuals of varying backgrounds who are qualified through maturity, experience, expertise, and the diversity of the members' racial and cultural backgrounds to assure complete and adequate review of activities commonly conducted under the College's auspices, and to ensure respect for its advice and counsel for safeguarding the rights and welfare of human subjects. The IRB shall possess the professional competence necessary to ascertain the acceptability of proposals in terms of institutional commitment and regulations, applicable law, standards of professional conduct and practice, and community attitudes. c. The determination regarding whether a given activity should be considered human subjects research will be made by the IRB or its designee. d. Certain categories of research involving little or no risk to subjects need not be reviewed and approved by the full IRB, but are eligible for less intensive review procedures. e. The IRB shall develop and promulgate appropriate categories of research and determine the review procedures for each category. f. The IRB shall apply additional criteria (PDF) during the review of research involving Excelsior College prospective and enrolled students, faculty, staff, or alumni.

Procedure

Planning a Research Project

When an investigator plans to conduct research involving human subjects, he/she is advised to contact the chair of the IRB (or a designee) who also functions as the human subjects research officer (HSRO) as early as possible. Email them at IRB@excelsior.edu Aspects of a project which may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way which will facilitate approval.

Determining Human Subjects Involvement

The initial determination as to whether a research project should be considered human subjects research should be made by the investigator. He/she should consult the HSRO (or designee) for advice on this question. Final authority for making this determination rests with the IRB or its designee.

In general, research that involves data gathered solely for internal use (e.g., program evaluation or institutional research) would not need to be reviewed. If, however, the results of this research will be disseminated to audiences external to the College, then the research must receive prior approval. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the project director would be advised to submit the project for approval prior to initiating the research.

Project Categories

Once it has been determined that an activity is to be considered human subjects research, it will be reviewed under one of two categories: Project Category I is eligible for "expedited review" and Project Category II requires "full review." The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the IRB or its designee may require review under another category. The researcher can always request a higher level of review than that required.

Below are listed the project categories, along with examples of the types of projects included in each category:

Expedited Review: The review is carried out by the authorized designees of the IRB (usually including the Human Subjects Research Officer.) The designees may approve the project, request additional information or submit the proposal to the IRB for full review and approval. The investigator is notified in advance of this review. If the investigator questions any determination made under expedited review, he/she has the option of requesting a full review by the IRB, which will make the final determination.

Full review: The review is generally conducted at the next convened meeting of the IRB. The IRB meets on an as-needed basis. Investigators are welcome to attend the meeting and answer questions or provide additional information regarding their projects.

Conditions of Approval

Approval of a project by the IRB only signifies that the procedures adequately protect the rights and welfare of the subjects and should not be taken to indicate College approval to conduct the research.

Approval of a project by the IRB applies only to the procedures submitted in the proposal. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of human subjects. The investigator must also report to the IRB any problems that arise in connection with the use of human subjects.

Approval for projects is valid for one year only. Investigators must request a continuation for the approval yearly if the activity lasts more than one year. Only two (2) continuations will be granted for a given project. After three years, the project must be resubmitted.

Student Research

All student investigators must have a faculty supervisor who is responsible for insuring that all procedures of the approval are complied with by the investigator. The faculty supervisor must sign the proposal certifying that the project is under her/his supervision.

All student investigators must have their research proposal approved by the Review Board at their respective college and provide proof of that approval.

Informed Consent

"Informed consent" means the knowing consent of an individual, or her/his legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion. An investigator shall seek consent only under the following circumstances:

Sufficient opportunity is provided to the prospective subject or her/his representative, to consider whether or not to participate;

The possibility of coercion or undue influence is minimized;

The information that is given to the prospective subject, or her/his representative, shall be in language understandable to the subject or representative; and

The subject, or her/his representative, cannot be made to waive or appear to waive any of her/his legal rights, or release or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.

The federal regulations detail the following basic elements of information necessary to such consent:

A statement that the study involves research, an explanation of the purpose of the research and the expected duration of the subject's participation and a description of the procedures to be followed;

A description of any foreseeable risks or discomforts to the subject;

A description of any benefits to the subject or to others that may be reasonably expected from the research;

A statement describing the extent to which confidentiality of records identifying the subject will be maintained;

An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and whom to contact in the event of a research-related injury;

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which that subject is otherwise entitled and the subject may discontinue participation at any time; and

For research involving more than minimal risk, an explanation that the College does not have a formal plan or program to provide medical treatment or compensation for any injury which occurs as a result of the subject's participation (the subject should also be informed that this does not waive any of her/his legal rights).

When appropriate, one or more of the following elements of information shall also be provided to each subject:

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject ;

An identification of any procedures that are experimental;

A statement that the research may involve risks to the subject that are currently unforeseeable;

Anticipated circumstances under which the subject's participation may be terminated without regard to the subject's consent;

Any additional costs to the subject that may result from participation;

The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to participate will be provided to the subject; and

The approximate number of subjects involved in the study.

In projects where subjects are determined to be at risk, the actual procedure utilized in obtaining "legally effective informed consent" must be fully documented. This is accomplished by using a written consent form embodying all of the elements of information required for the project. The consent form must be read by or to the subject or her/his legally authorized representative and signed by the person giving consent. A copy of the consent form should be given to the person signing the form and the signed form must be maintained in the investigator's files for an indefinite period of time following completion of the study.

The Institutional Review Board has designated a sample Volunteer Agreementform (PDF) that can be used as a guide in preparing the consent form that will actually be used in the research project or activity. PLEASE NOTE that the final form that you administer must first be approved by the IRB before it can be legally administered.

In rare cases, where these procedures will surely invalidate important objectives of the project, IRB approval of modified procedures may be sought.

In projects where risk to subjects has been determined to be no more than minimal, provision may be made for oral or written presentation and consent. Under this procedure, the subject is informed of those basic elements of consent which are applicable to low risk procedures and no signed document is necessary on the part of the subject. However, the Board must approve a sample copy of the presentation. A major exception to this policy occurs when research involves persons under the age of 18 as subjects, in which case, written consent from a parent or a guardian is usually required.

In some cases, the IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent or may entirely waive the requirement to obtain informed consent.

Researchers requesting an expedited review do not need to submit the Volunteer Agreement or Informed Consent pages of this application. All other researchers must include these pages in their application.